Governor Acts On Drug Review Panel Legislation

SPRINGFIELD - Gov. George H. Ryan today amendatorily vetoed legislation approved this spring that would have stripped a state panel of its authority to evaluate generic drugs to be substituted for name-brand drugs and clarified the group's role.

Ryan, a retired pharmacist, asked for legislative concurrence with his changes to House Bill 2256, which would narrow the Technical Advisory Council (TAC) review of generic name drugs to those determined to be "critical dose drugs" prior to allowing them to be substituted for brand-mane drugs.

"Through this action, I'm seeking to maintain an important protection for Illinois consumers," Ryan said. "I want to ensure that a subset of drugs whose margin of error is so small they could be life threatening will continue to receive close scrutiny."

Critical dose drugs require carefully measured amounts and routine monitoring of the patient, and exhibit a narrow margin between a lethal and effective dosage. There are about two dozen drugs on Illinois' drug formulary that would meet this definition and are used in the treatment of serious medical conditions, such as heart problems, epilepsy, diabetes, stroke and mental illness.

"Over the past 20 years, the Technical Advisory Council has competently performed the vital function of establishing safeguards to protect our citizens from the dangerous consequences of inappropriate switching of these highly sensitive medications," Ryan said.

The TAC was established in 1978 to evaluate generic drugs and is made up of a panel of volunteer doctors, pharmacists and pharmacologists appointed by the director of the Illinois Department of Public Health. Based on TAC recommendations, the Department publishes a Drug Production Selection Formulary that details for Illinois pharmacists those generic drugs that can be substituted for name brands.

While proponents of House Bill 2256 argued that TAC was costly and duplicated the U.S. Food and Drug Administration's (FDA) "Orange Book" of therapeutically-equivalent drugs, Ryan recounted examples of generic drugs approved by the FDA that later were determined unsafe by TAC.

They include phenylbutazone and oxyphenbutazone, anti-inflammatory agents that were found to have the ability to destroy bone marrow; cyclosporine, an immunosuppressent for organ transplants later was shown to have erratic absorption that could result in either toxicity or possible organ rejection; and warfarin sodium, a blood thinner that if taken in the slightest variation can be life-threatening.